An Open-Label, Rollover Study for Participants With Thyroid Eye Disease Previously Enrolled in Amgen-Sponsored AMG 732 Studies and are Primary Proptosis Non-responders or who Relapsed During the Safety Follow-up
This research study, called an 'open-label rollover study,' is for individuals with Thyroid Eye Disease (TED). It specifically targets those who previously participated in another study for the drug AMG 732 but didn't experience enough improvement in their bulging eyes (proptosis) or whose symptoms came back after the previous study ended. The main goal is to check if continuing treatment with AMG 732 can reduce eye bulging. Researchers will also look at how the body handles the drug and track any side effects. This is a Phase II study, meaning it's still in the earlier stages of exploring the drug's effectiveness and safety.
At a glance
What is this study about?
This study is a follow-up for people who have Thyroid Eye Disease (TED) and have already been involved in another research study using a medicine called AMG 732. Sometimes, in those previous studies, participants might not have seen enough improvement in their bulging eyes (doctors call this 'proptosis'), or their symptoms might have started to return after they finished the first study. This new study gives them another chance to receive AMG 732 to see if it can help further.
The main thing the doctors want to find out in this study is if AMG 732 can help reduce eye bulging for these participants. They will be measuring this carefully. They'll also be looking at how the body uses and processes the drug, which helps them understand the best way to give it. Importantly, they will also keep a very close eye on any side effects or unexpected problems that might happen during the study.
This type of study is called a 'Phase II' study, which means it's an earlier stage of research. The aim is to gather more information about how effective and safe the drug is before it can potentially be tested in larger groups of people. It's an 'open-label' study, too, which means both you and your study doctor will know you are receiving AMG 732.
Key takeaways
- This study is for adults with Thyroid Eye Disease who previously received AMG 732.
- It aims to see if continued AMG 732 can reduce bulging eyes if previous treatment wasn't enough or symptoms returned.
- You will receive AMG 732 and be closely monitored for effectiveness and side effects.
- It's a Phase II study, gathering more information on the drug's safety and impact.
- Your safety and well-being are a priority throughout the study.
Who may be eligible?
To be considered for this study, you must have Thyroid Eye Disease and have previously participated in a specific research study for the drug AMG 732 sponsored by the company Amgen. You also need to be an adult, 18 years of age or older.
Crucially, you must meet one of two conditions related to your previous AMG 732 study: either your bulging eyes (proptosis) did not improve enough during that study, or your eye bulging got worse again after that study finished. This means the study is specifically for those who might need further treatment for their condition.
Both men and women can take part in this study, as long as they meet the age and previous study participation requirements.
Could this study suit you?
Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.
- Are you 18 years old or older?
- Do you have Thyroid Eye Disease?
- Have you previously taken part in an Amgen-sponsored study using AMG 732?
- Did your eye bulging not significantly improve in that previous study, or did it get worse again afterwards?
What does participation involve?
If you decide to take part in this study, you will be given the study medication, AMG 732. Since this is an 'open-label' study, you will know you are receiving the active drug. You will have regular visits to the study clinic where doctors and nurses will monitor your health, check for any side effects, and measure your eye bulging using a special tool. They will also take blood samples to see how your body is handling the medication. The exact number of visits, tests, and the total duration of the study will be explained in detail by the study team, as it varies depending on your treatment schedule and follow-up needs. There will also be a period after you finish taking the medication where your health will continue to be monitored.
Potential risks and benefits
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Common questions
What is Thyroid Eye Disease?
Thyroid Eye Disease (TED) is an autoimmune condition where the immune system attacks the tissues around the eyes, often causing inflammation, redness, discomfort, and bulging of the eyes.
What does 'proptosis' mean?
'Proptosis' is the medical term for bulging or protruding eyeballs, which is a common symptom of Thyroid Eye Disease.
What does 'open-label' mean?
'Open-label' means that both you and your study doctor will know that you are receiving the study medication (AMG 732), rather than a placebo or another treatment.
What is a 'Phase II' study?
A Phase II study is an earlier stage of research that explores if a new treatment is effective and safe for a specific condition. It typically involves a relatively small group of people.
Can I join this study if I've never taken AMG 732 before?
No, this specific study is only for people who have previously participated in another Amgen-sponsored study involving AMG 732.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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